Medtronic has issued a recall of the controller driveline cover of the company’s HeartWare Ventricular Assist Device (HVAD) system.

The Medtronic HVAD system was approved as a bridge to heart transplantation in 2012.

Since then, it’s been fraught with problems, leading the company to stop selling the device in June 2021 for safety concerns, as reported by theheart.org | Medscape Cardiology.

In an urgent letter to healthcare professionals dated November 29, the company says the controller driveline boot cover of the HVAD system can harden over time, creating difficulty or an inability to slide the cover back to disconnect the driveline from the controller.

If the driveline cover becomes stiff, access to the driveline connector may be delayed, “which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed,” the letter reads.

Medtronic says the problem is due to “plasticizer loss and may be accelerated by environmental factors.”

No Serious Injuries or Deaths

Between January 3, 2017, and September 15, 2022, Medtronic received 33 complaints of a hardened and/or stuck driveline cover after multiple years of use.

In all 33 events, the driveline cover was either hard to remove or could not be manipulated by hand and required servicing or other tools for removal.

In 25 of these events, negligible or no patient harm was reported, Medtronic says.

In four cases, a hardened driveline cover was observed for patients who were hospitalized for unrelated reasons. The driveline cover was removed, which required brief time off the pump.

In the remaining four instances, a hardened driveline cover was identified during a routine clinic visit or following a controller alarm, for which the patient was hospitalized for servicing and removal of the driveline cover.

“No critical harms or deaths have been attributed to this issue,” the company says.

Medtronic is advising clinicians to inspect the boot cover routinely and to report hardened boot covers to the Medtronic field representative for further assessment and/or servicing.

The Medtronic letter asks customers to complete a customer confirmation form and return it to [email protected]

More information can be found on the FDA’s Recalls Related to HVAD System web page.

Problems related to the Medtronic HVAD System should be reported to the FDA’s MedWatch program.

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